Pfizer Inc. has announced the FDA’s newest indication for atorvastatin calcium (Lipitor drug): to reduce the risk of stroke and heart attack in people with type-2 diabetes and to reduce the risk of stroke in people without diabetes but with other risk factors.
The FDA’s decision was based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS). This landmark trial involved more than 2,800 patients with type-2 diabetes, near-normal cholesterol levels, and at least one other risk factor (e.g., high blood pressure or smoking). The results showed patients taking generic atorvastatin experienced nearly 50% fewer strokes than those taking placebo. The trial was stopped two years early because of the strong benefits shown.
This additional indication also reflects findings from The Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA). In this trial, atorvastatin also reduced the relative risk of stroke by 26% compared with placebo.
According to the American Diabetes Association’s recommended treatment guidelines, adults with type-2 diabetes should be considered for statin therapy regardless of their low-density lipo-protein-cholesterol levels.